MAUDE Adverse Event Report: BECTON DICKINSON BD INTELLIPORT¿ TABLET KIT; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	516704
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.Investigation summary: one photo was received by our quality team for evaluation.From the photo, a tablet displaying two 6ml doses of propofol with a one minute difference was observed.The certificate of compliance was reviewed and there are no non-conformances associated with this issue during production of this batch.The tablet / gateway logs were reviewed and it was found that before the two consecutive doses were recorded, the user attached and detached multiple times.This prompted the system to ask the user to manually enter the dose into the system.This resulted in the two recordings: one from the user injecting the 6ml and one from the entered 6ml dose.Therefore, the system is working as designed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd intelliport¿ tablet kit recorded a duplicate dosage when the syringe was left attached for 60 seconds.The following information was provided by the initial reporter: "it was reported that user notified that the "weird finding - left syringe attached for 60 seconds - and it came up with duplicate 60mg entry" on intelliport tablet.".

• Brand Name: BD INTELLIPORT¿ TABLET KIT
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14401371
• Report Number: 2243072-2022-00685
• Device Sequence Number: 5607319
• Product Code: PHC
• UDI-Device Identifier: 00382905167041
• UDI-Public: 00382905167041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 516704
• Device Catalogue Number: 516704
• Device Lot Number: 20028T04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown